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The Food Safety Enhancement Program approach to a preventive control plan

Although the Safe Food for Canadians Regulations (SFCR) came into force on January 15, 2019, other requirements will be introduced in 2020 and 2021 based on food commodity, type of activity and business size. For more information, refer to the SFCR timelines.

Introduction

The Food Safety Enhancement Program (FSEP) is one example of a type of preventive control plan (PCP). FSEP is based on the Hazard Analysis and Critical Control Point (HACCP) principles and, for many years, this program has been implemented by meat, dairy, processed fruits and vegetables, shell eggs, processed eggs, honey and maple food operators as well as hatcheries. FSEP specifies the requirements for an effective HACCP system to ensure food is prepared under sanitary conditions and is safe to eat.

It is important for businesses operating under an FSEP plan developed prior to the Safe Food for Canadians Regulations (SFCR) to:

review their FSEP plan against the preventive control requirements of the SFCR; and

verify that you are using control measures that are shown by evidence to be effective

Once reviewed and revised, as necessary, businesses may continue to use their written FSEP as their PCP and be in a good position to demonstrate compliance with the preventive control requirements of the SFCR.

Purpose

The Canadian Food Inspection Agency (CFIA) created this document as guidance to help regulated parties comply with the Safe Food for Canadians Regulations.

It's your choice

You may use other guidance developed by provincial governments, industry associations, international partners or academic bodies as long as they can achieve the outcomes identified in the regulations. Always ensure that the guidance you choose is relevant for your particular business, product or products, and market requirements.

What is included

The document describes the key components of a written Food Safety Enhancement Program, as well as information on program changes to consider under the SFCR.

Refer to the Tell me more! section for additional sources of information that may help you update your FSEP.

What's not included

The document does not discuss the municipal and provincial processing requirements that may apply to your activities.

Roles and responsibilities

Food businesses are responsible for complying with the law. They demonstrate compliance by ensuring that the commodities and processes for which they are responsible meet regulatory requirements. If a written PCP is required, the food business develops a PCP with supporting documents, monitors and maintains evidence of its implementation, and verifies that all control measures are effective.

CFIA verifies the compliance of a food business by conducting activities that include inspection, and surveillance. When non-compliance is identified, the CFIA takes appropriate compliance and enforcement actions.

The Food Safety Enhancement Program

I. General

You prepare, keep and maintain a written FSEP plan that meets the requirements of section 89 of the SFCR. The plan outlines the control measures you develop and implement to ensure that your food is safe and fit for consumption and the measures you apply to ensure compliance with the consumer protection and animal welfare requirements, as applicable. Your FSEP outlines:

Requirements /critical limits

The criteria that have to be met or the critical limits that have to be met for each critical control point (CCP) in your HACCP plans.

Keep in mind

You need to review and update, as necessary, the requirements with the preventive control requirements in Part 4 of the SFCR.

Preventive controls

A description of the control measures to ensure compliance with the requirements set out in sections 47 to 84 of the SFCR. The written preventive controls describe:

the name or position title of the individual responsible for each control measure

the control measures (programs, standard operating procedures, tasks and activities) conducted to prevent, reduce or eliminate to an acceptable level any hazard

the process controls applied which contribute to the reduction of a hazard but are not designed to eliminate or reduce it to an acceptable level

the titles of the records completed to show that the preventive controls are implemented and effective

Monitoring procedures

A description of the monitoring procedures to ensure that the control measures are carried out correctly and consistently. The written monitoring procedures describe:

the prerequisite, CCP or process control measures being monitored

the requirements, criteria, critical limits or specifications (quantitative such as temperature in degrees Celsius or qualitative such as pooling of water) that have to be met and define the limit of acceptability

each monitoring activity (test, measurement or observation) conducted for each measure

name or position title of the person responsible to conduct each monitoring activity

detailed methods or instructions for conducting each monitoring activity

a frequency that can be measured and audited (for example, as required cannot be measured or audited)

a minimum frequency of once per year

names of the records completed to document the results of the monitoring activities

name or title of personnel responsible for the monitoring procedures and the assessment of the results

Note

The document Monitoring procedures provides additional information on key elements to consider in the development of monitoring procedures and types of monitoring procedures.

Corrective action procedures

A description of the corrective actions when there's a deviation or deficiency with:

the control measures applied in a prerequisite program that compromises their effectiveness and compliance with the requirements/ criteria

the control measures and process controls of a CCP that compromises their effectiveness and compliance with the critical limits set for the CCP

The corrective procedures:

identify the name or title of the person responsible for the corrective action procedures

Note

Keep in mind

Under the SFCR (section 89):

Written monitoring and corrective actions procedures are required only for CCPs, however, these procedures help ensure the effective implementation of any control measure you apply and are recommended for your prerequisite programs as well.

Monitoring activities can provide evidence on the implementation and effectiveness of any control measure you apply.

Verification procedures

A description of the verification activities to confirm and demonstrate that all preventive controls, monitoring activities and corrective actions outlined in your program are consistently implemented and are effective in achieving the intended outcome.

Verification procedures apply to the:

HACCP plan (to verify that all food safety hazards are identified)

CCPs and process controls applied (to ensure critical limits are met)

control measures for hazards that are not part of a CCP

measures taken to ensure that the requirements on the humane treatment of animals are met

monitoring procedures

corrective actions procedures

Your verification procedures:

identify who conducts the verification activities

You assign the verification activities to someone who is not responsible for or involved in the monitoring activities.

describe the verification activities such as:

direct observation of monitoring activities

interview of persons responsible for monitoring and deviation procedures

direct observation of corrective actions taken, if possible

review of records documenting the monitoring activities

review of records documenting the actions taken in response to a deviation

product testing to confirm that the CCP is properly implemented and achieves the intended outcome

describe the frequency of each verification activity

identify the records that are completed to document the verification activities completed and the results of those activities

Note

Keep in mind

Verification procedures apply to your prerequisite program as well as the CCPs and process controls.

Verification activities provide evidence on the implementation and effectiveness of any preventive control you apply.

You may verify your program at a frequency appropriate for your business however it is recommended that you verify your program at least annually.

Record keeping

A description of the documents (records) completed to substantiate that your preventive control plan has been implemented and to provide evidence that your control measures are effective. You ensure the integrity of the records by:

keeping up-to-date the version of the records to be completed:

to demonstrate that the control measures are implemented

to capture the results of the monitoring procedures

to capture the corrective actions taken

providing instructions on how to complete the records that describes:

the fields to complete

how to complete the record:

objectively

factually

accurately

legibly

using permanent ink

the format for presenting the information in each field, for example:

numerical reading such as a temperature

a summary, on what was done or observed

a selection from a list of choices

the signing and dating of records by the person responsible for completing them

providing instructions on the filing and retention of records

The document Record keeping procedures provides guidance that may help you establish records and ensure the integrity of all the records you generate.

Keep in mind

Under the SFCR:

The documents (records) you generate to show your preventive controls are implemented and effective have to be retained for a period of 2 years (rather than 36 months).

Documents (records) on the treatment of low-acid foods packed in hermetically sealed package, that are not kept refrigerated or frozen, have to be retained for 3 years.

II. Program Responsibilities

Developing, implementing and maintaining an effective program depends on knowledgeable, experienced and committed management and employees working together to identify food safety hazards and determine how to control them.

External consultants may provide expertise that is missing and assist in the development of your FSEP however you remain responsible for your program.

Senior management commitment

The responsibilities of senior management include:

the maintenance and operation of the establishment in compliance with the SFCR

ensuring that food safety is fully embedded in every level of the food business

Senior management demonstrates commitment to their FSEP by:

providing the resources and time needed for the development, implementation and maintenance of the FSEP and training of staff. For example:

providing financial resources to ensure that the construction of the premises, its internal fittings, the installation of the equipment, the maintenance of the premises and equipment, as well as the supplies required to perform the above, meet regulatory requirements and support the program

providing designated personnel with the authority to initiate, implement and record corrective actions

communicating to employees the importance of complying with the program, including any regulatory requirements related to food safety, and the importance of reporting problems to the identified person(s)

allowing designated management personnel to enforce compliance of the food safety procedures identified in the establishment's FSEP for any person entering or working within the facility

allowing the continuous improvement of the program to ensure its effectiveness through the validation of control measures, by making changes to the system as a result of corrective actions or reassessment activities, and through the use of HACCP team meetings

providing sufficient time for HACCP team meetings

assigning a HACCP team leader responsible for the development, implementation, maintenance and re-assessment of the program

staying informed of the program's performance at all times

attending HACCP team meetings periodically and keeping those responsible for finances informed of items that will require financial support

A letter of commitment signed annually by a member of senior management confirms the:

support for the development and implementation of an effective program

commitment to the preparation of food in compliance with all regulatory requirements

HACCP team

The responsibilities of a HACCP team include:

providing assistance to the team leader for the development, implementation, maintenance and re-assessment of the program

holding meetings regularly to discuss matters such as:

amendments to the program

deficiencies with the program

root causes of deviations, deficiencies or non-compliances

action plans to correct deviations, deficiencies or non-compliances

informing senior management of the program's performance and the verification results on a regular basis and providing the information necessary to obtain the support and resources needed to correct the issues

The procedure followed to inform senior management outlines the:

name or title of person responsible for providing the information

name or title of the senior management who receives the information

frequency at which the information is communicated

method used to provide the information

process used to demonstrate that the communication took place

Keep in mind

While the SFCR do not have PCP requirements on management roles and responsibilities, it is a recommended practice and you are encouraged to outline these in your FSEP.

FSEP document

Having the first page of the prerequisite programs, HACCP plans and process controls signed and dated by the HACCP team leader or a member of senior management provides the confirmation that the HACCP system is approved and will be implemented as specified. It is recommended that the document be signed:

upon implementation

after modifications are made that impact the control of a hazard

after verification activities

Dating all pages of the prerequisite programs, HACCP plans, process controls and supporting documentation such as standard operating procedures ensures that the correct version is implemented. It is recommended that the document be dated:

upon implementation

after modifications are made

Note

For the use of electronic signatures or signature stamps, it is a good practice to have measures to ensure their integrity and authorized access. You may incorporate the date with the electronic signature or signature stamps.

III. Prerequisite programs

The design and construction of an establishment and equipment, as well as the condition of the premises and equipment, have to be suitable for the production of safe food production. The establishment also has to be maintained and operated in a clean sanitary condition that prevents the contamination of a food. The requirements that apply to the maintenance and operation of an establishment can be found in Division 4, sections 49 to 81, of the SFCR. The following prerequisite programs address these requirements:

A. Premises

This prerequisite program is intended to address the requirements set out in sections 56 to 71 of the SFCR.

1. Outside property (section 56 of the SFCR)

The land that forms part of your establishment and the location of your establishment may be a source of hazards such as pests and airborne microbial or chemical contaminants. These hazards may enter your establishment and present a risk of contamination to your food. To prevent or eliminate the hazards you:

maintain the surrounding land/roadways free of debris, refuse and ensure it is well drained

keep the grass trimmed and remove dead vegetation

regularly clean and cover external waste containers with tight fitting lids that are resistant to the entry of animals and pests

If your establishment is located near a source of contamination such as livestock or agricultural activities, you can protect your food from the hazards these activities may present by:

using filters at the air intake points to remove airborne contaminants from the incoming air

2. Establishment (sections 57 to 71 of the SFCR)

2.1 Design, construction and maintenance (sections 57 to 58 and 60 to 62 of the SFCR)

The design and construction of your establishment prevents hazards that may be present from posing a risk of contamination to your food. For example:

walls, floors and ceiling joints are sealed to prevent the accumulation of contaminants such as dust, dirt, micro-organisms, and food particles and allows for effective maintenance, cleaning and sanitizing

walls, doors, windows, ceilings, overheads and other structures in rooms or areas where food is prepared, manufactured, stored, packaged, received or shipped are:

smooth

non-absorbent

impervious to moisture

cleanable

free of noxious constituents

durable

resistant to deterioration

hard-to-reach areas are sealed to prevent build-up of contaminants

the design allows for easy access to all areas for maintenance, cleaning and sanitizing activities

ceilings and overhead structures are designed to minimize the build-up of dirt and condensation

floors have a slope that directs wastewater to the drains

floor drains are readily accessible for maintenance, cleaning and sanitizing

floor drains are equipped with traps, allow the rapid removal of wastewater, prevent pooling and flooding of the surrounding areas

the drainage and sewage systems are equipped for the prevention of backflow, sewer gases, pests and other contaminants from entering the establishment through the plumbing system

Note

If the design of your facility does not allow for the effective separation of incompatible operations, or prevent cross-contamination, control measures to prevent cross-contamination are needed as part of the General Food Hygiene Program and/or Sanitation Program.

Movement of persons and things (section 59 of the SFCR)

The movement of persons and things is controlled to prevent contamination of the food.

Access to the establishment is secure.

The traffic and process flow is designed to prevent cross-contamination and hygienic operations.

prevents the flow of air from one area to another which may be a source of airborne contaminants

lowers the temperature and humidity to a level appropriate for the activities conducted by removing warm moist air from the facility

has close-fitting screens or filters at the air vents to prevent the entry of insects, dust, smoke, steam, odours, and contaminated air

is easily accessible and can be properly disassembled for cleaning, maintenance and inspection

is maintained in good operating condition by cleaning or replacing filters regularly, as appropriate for the effective exchange of air

The document condensation provides information on measures you may apply to prevent condensation and the contamination of your food with condensation that cannot be prevented.

2.4 Waste and inedible/food disposal (section 66 of the SFCR)

You handle and dispose of waste, such as garbage, discarded packaging, broken pallets, discarded construction materials, and inedible products or food waste in a manner that prevents the contamination of your food. For example:

the utensils and containers used to collect, hold and dispose of waste are identified

the frequency at which you remove the waste prevents its accumulation and the attraction of pests that may contaminate your food

the waste is stored and covered in a manner that prevents the release of objectionable odours

the equipment used to contain and store waste is leak proof

the drainage and sewage system can handle the volume and type of liquid waste created and prevents pooling

contaminated materials and waste are removed from the establishment by designated employees using predetermined routes

3. Sanitary facilities (section 67 of the SFCR)

3.1 Employee facilities

Your establishment has the necessary sanitary facilities for employees to maintain personal cleanliness such as:

hand cleaning and sanitizing stations

lavatories

showers

drinking water stations

break rooms and change rooms

The sanitary facilities:

are readily accessible

are maintained

are equipped appropriately

can accommodate the number of employees that could be using them at the same time

For example:

lavatories are equipped with:

well- functioning toilets

a continuous supply of toilet paper and liquid hand soap to meet the needs of the employees

faucets with hand-free water supply function

sanitary hand drying supplies or equipment

waste receptacles

hot and cold/warm potable running water

the location of the lavatories does not present a risk of contamination.

There is an anteroom or outer foyer that separates the lavatories from the areas where you conduct your food activities

hand washing notices are posted in the lavatories

the sinks are designed and of a size that makes the hand washing process easy and effective

there are change rooms with separate storage space for employee personal clothes and protective work clothes to prevent the risk of contamination the clothing worn by employees may present to a food

there are break room facilities for employees to prevent them from eating and drinking in areas that may present a risk of contamination to a food

3.2 Hand-washing stations and sanitizing installations

Your facility has and maintains the necessary installations for the cleaning and sanitizing of hands and footwear to prevent the contamination of a food. For example:

Hand washing and sanitizing stations are located in areas where employees need to wash their hands, such as entrances to food preparation areas, and of a quantity that can accommodate the number of employees that could be using them at the same time.

Hand-washing notices are posted in entrances to food preparation areas.

Potable water is used in the hand and footwear sanitizing stations and the sanitizing chemicals used are approved, appropriate for use and maintained at the concentration needed to be effective.

The water temperature is warm enough to soften residues on hands and allow the soap to produce the lather needed to remove waste and contaminants but comfortable for the hands.

The water pressure is strong enough to allow for dirt and contaminants to be easily removed from the hands.

Hand cleaning and sanitizing stations that do not use water are equipped with a solution that allows for the effective removal of waste and contaminants.

4. Water/ice/steam (sections 70-71 of the SFCR)

The water, ice and steam used that can come into contact with food do not present a risk of contamination to the food. For example:

you use potable water such as municipal water

you have water safety procedures that:

identify the name or title of personnel responsible for its implementation

B. Food conveyances, purchasing, receiving and storage

1. Food conveyances (sections 72-73 of the SFCR)

The conveyances used to transport food to and from your establishment do not present a risk of contamination to a food and protect the food from contamination from other food, dust, pests and the exterior environment. For example, the conveyances:

keep refrigerated food at a temperature between 0°C and 4°C and frozen food at −18°C or less

are equipped with instruments that control, indicate and record temperature and humidity levels where necessary

are never used to transport materials or substances that present a risk of contamination to a food

You request information on the previous materials or things that were carried in the conveyance and if necessary, proof that it was cleaned and sanitized.

can be and are maintained in a clean and sanitary condition

Conveyances are verified before you load or unload food to ensure they're clean, sanitary, in good condition and do not contain chemicals or substances that may contaminate the food.

Bulk transport tankers can be completely drained for cleaning.

The food is loaded on and unloaded from a conveyance in a manner that does not present a risk of contamination to the food. For example:

you avoid using equipment that may damage and contaminate the food

you ensure there's a good seal, between the conveyance and the establishment, at the site where food is loaded and unloaded to prevent pests from coming into contact with the food

2. Purchasing, receiving and storage

2.1 Purchasing and receiving (section 47(2) of the SFCR)

The incoming ingredients, products and materials you receive in your establishment are suitable, permitted for use and do not present a risk of contamination to your food. For example:

the packaging materials that are or may come in direct contact with the food you prepare, such as paper wraps, waxed cardboard boxes, plastic films, synthetic casings, nettings, trays, absorbent pads, pouches and bags are suitable for their intended use and do not present a risk of contamination to your food

the food and ingredients received to prepare your food are not contaminated, are permitted for use, and do not present a risk of contamination to the food

the construction materials, coating and joint sealants used in your establishment do not contain noxious substances, are non-absorbent, impervious to moisture, cleanable, durable and resistant to deterioration

non-food chemical products that come into contact with your food, such as processing aids, and are used on food contact surfaces such as cleaners, disinfectants and sanitizers are safe and suitable for use

You verify the incoming ingredients, products and materials when they are received to ensure that they:

are properly labelled and identified

are in good condition, not damaged or soiled

meet purchasing specifications

are accompanied with a certificate of analysis or letter of guarantee, as applicable

You identify and isolate, in a designated storage area, the food received as returns (food you prepared that has left your establishment) to prevent it from posing a risk of contamination to other food, as a result of mishandling and inadequate storage that may have occurred after the food left your establishment.

2.2 Storage (section 74 of the SFCR)

You store your food in a manner that protects it from contamination and you store non-food materials and chemicals in a manner that does not present a risk of contamination to your food. For example:

you store non-food chemicals, sanitizers and chemical agents:

in accordance to the manufacturer's instructions

in a designated, dry, ventilated area that prevents the risk of cross-contamination of your food, packaging material or food contact surfaces, from spillage or leakage that may occur

you follow "first in, first out" stock rotation principles to minimize deterioration which may make them ineffective for use

you store food on pallets or shelves off the ground to protect them against contamination from pests, including insects, rodents, and other vermin

If necessary, you install shelving units away from walls to allow for easy cleaning and to prevent pests from accessing the food.

You do not store food past the best before date.

you store conveyances and equipment:

in accordance to the manufacturer's instructions

in designated locations that are clean and away from employee traffic and food production areas

you store packaging materials:

under proper environmental conditions of temperature, humidity, and light to prevent their deterioration in accordance to the manufacturer's instructions

off the ground to prevent against contamination from pests, including insects, rodents, and other vermin

using "first in", "first out" principles to prevent their deterioration that may occur over time and make them a risk of contamination to the food

you store protective clothing in designated locations and off the floor so that they do not get contaminated and are accessible for use

C. Conveyances and equipment in the establishment

1. Equipment general (sections 53 to 55 of the SFCR)

The equipment you use is appropriate to the food and activity you conduct and function as intended.

Before using a conveyance or equipment, you verify that it is functioning as intended by the manufacturer.

If you use the same piece of equipment for more than one type of food, you ensure that the equipment is appropriate for all the types of food.

1.1 Design and installation

The conveyances or equipment you use are designed, constructed and maintained in a manner that prevents contamination of your food. For example:

the equipment and conveyances:

are properly installed:

have sufficient space around them for proper functioning

are accessible for maintenance, cleaning, sanitizing, inspection and disassembly for that purpose

are capable of delivering the requirements of the process and the sanitation program

do not have pits, cracks and crevices where contaminants may accumulate and microorganisms can grow

do not have internal horizontal ledges with hidden or hard-to-clean areas

are made of materials that are not affected by the constituents of the food such as the salt or acids

are equipped with protective shields, lids or covers to prevent contamination

the equipment:

exhausts to the outside of the facility if necessary to prevent excessive moisture

permits proper drainage and connects directly to drains, if necessary

the utensils are constructed of non-toxic materials, are easy to clean and sanitize and do not present a hazard to the food

1.2 Equipment maintenance and calibration

The equipment and conveyances are maintained, and if necessary, calibrated, so that they function as intended and do not present a risk of contamination to the food. For example:

you have a preventive maintenance program to ensure continuous proper function as intended that:

lists the equipment that may impact on food safety and require regular maintenance such as pasteurizers and their location

describes the schedule or frequency of preventative maintenance activities

describes the maintenance procedures to perform for each preventative maintenance task and the records completed to demonstrate their completion

maintenance procedures are based on the equipment manufacturer's manual or equivalent

the oil used to lubricate equipment that come into contact with the food are food grade

you inspect the conveyances or equipment regularly and repair them using spare parts that are approved or recommended by the manufacturer and replace equipment and utensils that are not in a good condition and cannot be repaired.

you have a calibration program to ensure instruments used to control, indicate, and record parameters are accurate. For example:

detect metal fragments based on type of food, target metal, and anticipated size

record critical processing times and temperatures

the calibration program:

lists the equipment monitoring and controlling devices that may impact on food safety and requires regular calibration

describes the calibration schedule or frequency of calibration activities

describes the calibration procedures to perform for each calibration task and the records completed to demonstrate their completion

Procedures are based on the equipment manufacturer's manual or equivalent.

D. Personnel

1. Training (section 75 of the SFCR)

Your personnel have the competencies and qualifications necessary to carry out the tasks and duties assigned to them to deliver the control measures needed to prevent, reduce or eliminate hazards from presenting a risk of contamination to your food. This includes the procedures outlined in your prerequisite programs, CCPs, process controls and the monitoring and verification activities. To ensure your personnel are trained you:

identify the training and knowledge required for each position/employee based on the tasks and duties they perform such as:

monitoring CCPs

measuring ingredients

detecting defects in food

calibrating, maintaining and operating equipment

receiving and handling food animals

duties defined within a post-mortem examination program

operating a stunning device for food animals

verify the effectiveness of the training by evaluating employees on the training they received

provide training when changes to your food business occur or when deviations arise due to lack of competencies or qualifications.

maintain the competencies and qualifications of your employees by providing them refresher training as needed

keep a record of the training provided, the names of employees who received each training and the date they completed the training

1.1 General food hygiene training

Your employees are trained on food hazards, food hygiene, clean and sanitary conditions and the hygienic practices to follow to prevent the contamination of food. For example:

2. General food hygiene program (sections 76 to 81 of the SFCR)

You have a food hygiene program that employees, contractors and visitors are expected to follow to prevent the contamination of your food. It describes, for example:

hygiene practices and behaviors that outline:

objects that may not be worn such as watches, necklaces, bracelets, earrings, fake nails, fake eyelashes, pens, paper clips, pins, and buttons are objects because they may present a risk of contamination to the food

the need to secure or cover objects worn that may present a risk of contamination but may not be removed such as religious apparel, wedding bands, medical alerts

substances that may not be used such as hand cream, nail polish or topical medicinal creams because they may present a risk of contamination to the food

storage of personal effects to prevent cross-contamination

methods for hand washing and sanitizing

proper use of protective clothing, hair coverings, gloves, footwear

prohibited practices at the establishment such as:

spitting

chewing gum

using tobacco products

eating

unnecessarily contacting the food

acting in any other way that presents a risk of contamination of the food

hygienic handling of food

proper use of utensils and equipment

procedures to prevent contamination as a result of the process flow, employee flow, product flow, equipment or incompatible operations

restricted access areas

procedures to follow to prevent cross-contamination when, for example:

product falls on the floor

product is exposed to dripping condensation

procedures for the reporting of disease, illness, symptoms and lesions that:

inform employees, contractors and visitors of the requirement that they report, to the person designated by you, their state of health when they have a disease or illness, symptoms of a disease or illness, or have an open or infected lesion

describes the process for determining whether a person with a communicable disease or with an open or infected lesion presents a risk of contamination to the food and the measures taken to prevent contamination

employees that present a risk of contamination are prevented from working in areas where food is exposed and handled

employees with an open cut or wound are not permitted to handle food or food contact surfaces unless the injury is completely protected by a secure waterproof covering

E. Sanitation and pest control

1. Sanitation (sections 50 and 52 of the SFCR)

You have a sanitation program to maintain your establishment and equipment in a clean and sanitary condition, free from the accumulation of dust, dirt, food residue, grease and other debris that may contaminate your food. For example, you:

describe cleaning and sanitizing procedures including the:

methods used for cleaning and sanitizing equipment and rooms

instructions on the equipment disassembly

housekeeping and sanitation procedures required during operations

pre-operational inspection procedures

procedures to verify the effectiveness of the cleaning and sanitation procedures such as, visual inspection, chemical residue or microbiological testing of the food contact surfaces and finished food

schedule/frequency for the sanitation of all equipment, rooms and areas within the establishment

use sanitizers and cleaners on food contact surfaces that are suitable for use and would not contaminate the food

identify chemical sanitizers with labels, tags or color coded containers to be able to differentiate between them

follow the manufacturer's instructions so that the sanitation chemicals are applied at the correct concentration, proper temperature and contact time and removed or rinsed as required to prevent cross-contamination of your food by the chemicals used

remove unprotected food and packaging material and protect the food contact surfaces before you begin cleaning or sanitizing

Note

2. Pest Control (sections 51 and 52 of the SFCR)

You have a pest control program that protects your facility against the entry and presence of animals that present a risk of contamination to the food. For example:

your facility (such as the roof, air intakes, foundation, walls, floors, drains, doors and windows), is designed and maintained to prevent the entry of animals, such as insects, rodents, birds or other vermin

your facility and premises are kept in a clean condition to discourage pests from harbouring

pests that enter your facility are caught and removed immediately

Note

The document Pest control provides additional information on control measures for pests and information on pest control programs.

F. Recall System

A recall system outlines the procedures for receiving, investigating and responding to complaints and the procedures for recalling a food that presents a risk of injury to human health.

1. Recall Plan

You have a recall plan in place that describes the:

food complaint procedures you follow for:

receiving, investigating and responding quickly to complaints related to food you have sold that represents, or may represent, a risk of injury to human health

notifying immediately the CFIA when you determine that a food is to be recalled

procedures for conducting a recall to remove foods from distribution, retail sale or consumer use

procedures on recall simulations to test your recall procedures at least once every 12 months

documents you prepare to capture the details on:

the complaint received, the results of the investigation and the actions taken based on the findings

how you conducted the recall simulation and the results of the simulation

Note

Keep in mind

Under the SFCR:

The requirements for investigation, notification, complaints and recall (do not form part of the PCP requirements. You can include these procedures in your FSEP or prepare, keep and maintain them separately from your FSEP.

Note the requirements to:

immediately investigate a complaint when you suspect on reasonable grounds that a food presents a risk of injury to human health

immediately notify the CFIA of the results of your investigation and take immediate actions to mitigate any risk of injury to human health when the results indicate that the food presents a risk

conduct a recall simulation, based on your procedures, once every 12 months, document the results of the simulation, and keep that document for two years

2. Traceability System (Part 5 of the SFCR)

A traceability system includes the measures you take to ensure a food is labelled with the information necessary to trace it and to prepare and retain documents that allow you to trace the movement of a food one step back and one step forward.

Note

You can obtain additional information on traceability requirements from CFIA's Traceability for food web page.

2.2 Labelling for traceability (section 92 of the SFCR)

You have measures in place that ensure the information necessary to trace a food is on your food label:

common name

lot code in the case of a consumer prepackaged food, or other unique identifier if not a consumer prepackaged food

name and principal place of business of the person by or for whom the food was manufactured, prepared, produced, stored, packaged or labelled

Keep in mind

Under the SFCR:

Traceability requirements are not part of the PCP requirements. You can include your traceability measures, and the documents you prepare, in your FSEP or keep them separate from your FSEP.

G. Operational Prerequisite Programs

1.1 Allergens, gluten and added sulphites

Food allergens, gluten and added sulphites are chemical hazards that you need to consider during your hazard analysis and when determining critical control points. You have control measures in place to:

prevent the risk of contamination of a food with allergens, gluten or sulphites which are not supposed to be present in the food

Health Canada maintains a list ofantimicrobial processing aids for which they issued a letter of no objection or an interim letter of no objection.

Vitamins, minerals and amino acids can be added to certain foods.

The foods to which they can be added and the vitamins, minerals or amino acids that can be added to them, are listed in Part D – Vitamins, Minerals and Amino Acids of the Food and Drug Regulations (FDR).

The minimal levels to be added and maximal levels that can be added are specified in Part B of the FDR.

You have control measures in place that ensure you add, to a food, only:

food additives that are permitted in accordance to their condition of use

nutrients that are permitted in accordance to the levels established in the FDR

processing aids that do not result in an unsafe food

You have control measures that:

ensure a food additive, vitamin, mineral or amino acid is permitted to be used or added to your food

is identical in composition and use to a substance or product that has already been assessed for safety and accepted by a food regulatory agency or food safety assessment body recognized by Health Canada.

all the equipment used to detect and remove foreign material and, as applicable:

the sensitivity of the detectors and the specifications on which it's based (for example, type of food, quantity/size of food, food packaging, location of equipment, speed of lines, potential environmental effects)

the mesh and/or gauge size of filters and sieves

the strength of magnets

how tasks are performed and their frequency

the measures to be followed when food is rejected by the equipment for the presence of foreign material and when foreign materials are removed by the equipment:

controls/mechanisms in place to ensure that the rejected product is effectively segregated and managed

examination procedures for rejected products

Note

When you determine that a foreign material detector is not working properly, all the food that has passed through the detector, since it was last tested to be working properly, is segregated and visually inspected or passed through a working detector.

When filters, sieves or magnets are found to be defective, the potential for contamination of products shall be assessed and appropriate actions taken.

The rejection of food by the detectors is assessed to determine if trends exist, such as, multiple false rejections that may suggest a malfunction or a calibration issue with the detector.

IV. Market fairness requirements

You describe the measures you apply to meet the consumer protection requirements referred to in section 89(1)(a) and (b) of the SFCR that apply to your food:

labelling

packaging

grading

standards of identity

net quantity

Your measures ensure the labels applied to your foods are accurate, legible and not misleading. For example, as part of your control measure you:

review the labels before they are printed

verify the labels before they are used and applied to the food

inspect the label on the final products

Keep in mind

Under the SFCR:

These are measures required in a PCP to meet the applicable market fairness provisions of the Safe Food for Canadians Regulations which are the food labelling, standards and grades requirements. Refer to CFIA's Labelling, standards of identity and grades web page for additional information on these requirements and the Industry labelling tool for information on the labelling requirements.

V. HACCP plan

You conduct a hazard analysis to identify the biological, chemical, and physical hazards that present a risk of contamination of your food and to determine the control measures needed to prevent, eliminate or reduce to an acceptable level the hazards identified, as required under section 47 of the SFCR.

To develop the HACCP plan for a food, required under section 89(1)(c) of the SFCR, you follow the 12 steps below.

Steps 1 to 5 are preliminary steps that enable you to conduct a hazard analysis.

Steps 6 to 12 incorporate the 7 principles of HACCP developed by the Codex Alimentarius Commission.

Note

Several foods may share similar hazards, processing steps or equipment. In this case, the foods or processes may be grouped into one HACCP plan.

1. Assemble the HACCP team

Assemble a HACCP team to develop the HACCP plans. The HACCP team:

has experienced personnel from different areas of the operation knowledgeable in:

food safety hazards common to the food prepared and processes applied

regulatory requirements

FSEP components

HACCP principles

is trained and qualified to carry out the work

has the necessary resources and time to deliver the HACCP system

2. Describe the product and identify its intended use

Describe the food and its intended use:

Name of process/food product type

The generic or common name of the product family or process covered by the HACCP plan.

Food product name

The brand name and/or common name of the individual food covered by the HACCP plan.

Important product characteristics

The physio-chemical characteristics of the product (such as, pH, aw, salt content, concentration of preservatives) that could affect food safety if not properly controlled.

Intended use

Based on the expected uses of the product by the end user (for example, ready-to-eat, ready-to-cook, for further processing.)

Packaging

All types of packaging used for the final food product (for example, drums, pails, cryovac bags, modified atmosphere, hermetically sealed).

The size of packaging (for example, consumer-size, bulk packs destined for further processing).

Intended shelf life and storage conditions

The intended shelf life such as the best before date of the food under normal marketing conditions at a given storage temperature.

Note

The document Shelf life studies provides an overview of the process for conducting a shelf life study.

Where the product will be sold

The points of sale, target groups of users such as retail and restaurants or more specific groups of consumers such as groups more vulnerable to food safety hazards, for example, infants and hospital patients.

Labelling instructions relating to food safety

Labelling instructions on handling, storage, preparation and usage of the food (such as cooking) which are important to ensure the food is safe to eat.

Special distribution control

Special controls required during transportation and storage (for example, temperature and humidity).

the sequence and interaction of all steps in the operation from receiving to final shipping;

the introduction of ingredients and intermediate products into the process flow

the introduction of product for reworking.

You may use Form 3: Process Flow Diagram to document this information and indicate whether there are biological, chemical or physical hazards associated with each processing step using the letters B, C or P.

The accuracy and completeness of the flow diagrams may be verified on-site.

5. Construct a schematic of the establishment

Prepare a schematic of the establishment for the foods or process categories covered by the HACCP plan. Schematics provide a basis for evaluating potential areas where cross-contamination by pathogens, foreign materials, chemicals or allergens may occur.

The schematic of your establishment shows the:

flow of all ingredients and the finished products

flow of packaging materials

employee traffic patterns throughout the establishment including change rooms, washrooms and lunchrooms

flow of wastes, inedible products, chemicals, and other non-food products that could cause a cross-contamination

hand/boot washing and sanitizing installations

You may use Form 4. Plant Schematic to document this information and indicate whether there are biological, chemical or physical hazards associated with cross-contamination points using the letters B, C or P.

The accuracy and completeness of the plant schematic may be verified on-site.

6. Identify and analyze hazards (HACCP principle 1)

Conduct a hazard analysis to identify the biological, chemical, and physical hazards that present a risk of contamination of your food, based on:

the information gathered in steps 1 to 5

employees' knowledge and experience on practical aspects of the establishment operations

documented production issues such as files on production rework, returned products, product complaints and recalls

Form 5: Biological Hazard Identification to list the biological hazards related to ingredients, materials that come into contact with the food, processing steps and points where cross-contamination may

Form 6: Chemical Hazard Identification to list the chemical hazards related to ingredients, materials that come into contact with the food, processing steps and points where cross-contamination may

Form 7: Physical Hazard Identification to list the physical hazards related to ingredients, materials that come into contact with the food, processing steps and points where cross-contamination may

Note

The document Conduct a hazard analysis provides additional information on how to conduct a hazard analysis, identify all potential hazards and evaluate the significance of a hazard identified.

Note

8. Critical limits (HACCP Principle 3)

Critical limits are clear and measurable criteria that distinguish between what is acceptable and/or unacceptable for a hazard identified by a CCP. The effectiveness of the control measures applied to prevent, eliminate or reduce to an acceptable level a hazard depends on their ability to keep the hazard within critical limits. One or more critical limits may be applied to control the identified hazards.

there's evidence, other than from the monitoring data, showing that the control measures at the CCP remained effective

there's evidence showing that the combined effect of the different control measures, applied at the CCP for that food, were effective in eliminating or reducing the hazards of concern to an acceptable level within the critical limits established

sample analysis results and/or other verification activities demonstrate that the hazards of concern were eliminated or reduced to an acceptable level within the critical limits established

You reprocess or further process food you determine to be unsafe only when the hazards of concern can be eliminated or reduced to an acceptable level, and there's no risk of contamination to other food.

You destroy and/or dispose as waste the food you determine to be unsafe for consumption.

Note

12. Record keeping (for CCPs) (HACCP Principle 7)

Keep records, as outlined in the section Record keeping procedures to demonstrate the effective application of a critical control point.

Note

The document Record keeping procedures provides guidance that may help you establish records and ensure the integrity of all the records you generate.

Process controls

You may apply process controls, a series of steps that contribute to the reduction of a hazard(s), prior to the CCP step at which the hazard(s) are controlled. These process controls are linked to the CCP.

VI. Validation documentation/Evidence of effectiveness

You validate, prior to implementing your HACCP plan, the effectiveness of the critical limits established for each CCP in controlling the hazard(s) identified. You have evidence showing that all the control measures you apply, to prevent, reduce or eliminate hazards, are effective.

The information used to conduct a validation includes:

scientific or technical publications, regulatory guidelines and standards on the critical limits or control measures applied

commissioned testing data specific for a piece of equipment (for example, pasteurizer) to demonstrate that the equipment is capable of meeting the selected critical limit

records you generate and maintain during the implementation of your FSEP

the templates for the records used to document monitoring, corrective actions and verification activities results to ensure it is designed to capture all information needed

Your reassessment procedures describe the:

individual(s) responsible for the reassessment activities

frequency of reassessment activities or "details and specifics" of reassessment activities (for example, you may specify that certain activities be conducted at various times over the course of the year)

title of record(s) used to document:

results of the reassessment

amendments to your FSEP

corrective actions taken

Keep in mind

Under the SFCR, you can verify that your control measures are consistently implemented and are effective at a frequency appropriate for your food business. It is recommended that you verify your entire FSEP program at least annually.

Revisions to your FSEP

You have procedures for amending your FSEP that describe:

name/title of personnel responsible for making the changes to your FSEP

name/title of personnel responsible for ensuring that the changes are implemented effectively

how you identify the revisions to your FSEP such as:

using a log book describing the revisions made:

Where the amendments were made in your program.

When (date) the changes were implemented.

You provide the revision date or number that correlates with the document you changed.

When the changes were reassessed and validated as implemented effectively.

Signed or initialed by a responsible person.

New HACCP plan

When you include a new HACCP plan or a new process to an existing HACCP plan, document:

the name of the new process/product

the risk category of the new process (high or lower risk category)

Keep in mind

Under the SFCR, you are not required to keep a list of the amendments you make to your FSEP plan, however it is considered a good practice.

Tell me more! Further reading

The following references contain information that helps explain food safety controls, demonstrates how to develop them, and provides examples. The CFIA is not responsible for the content of documents that are created by other government agencies or international sources.

International Commission on Microbiological Specifications for Foods (ICMSF). Microorganisms in foods 4: Application of the hazard analysis critical control point (HACCP) system to ensure microbiological safety and quality, Oxford: Blackwell Scientific Publications,1988

VIII. Forms

Form 1: Product description

Description of Form 1: Product description

Form 1 can be used to provide a description of each process or product type. The name of the process or product is described on the first line. You should describe the following:

Product name

Important product characteristics

Intended use

Packaging

Intended shelf life and storage conditions

Where the product will be sold

Labelling instructions relating to food safety

Special distribution control.

Form 2: List of ingredients and incoming materials

Description of Form 2: List of ingredients and incoming materials

Form 2 can be used to list all ingredients, including composition of formulated ingredients (with reference to other documents if needed), additives, processing aids and incoming materials that come in contact with or are used in preparing a food. The name of the process or product is described on the first line.

Form 3: Process flow diagram

Description of Form 3: Process flow diagram

Form 3 can be used to illustrate the flow of your operation using a diagram. The name of the process or product is described on the first line. Your process flow diagram on line 2 should illustrate:

the sequence and interaction of all steps in the operation from receiving to final shipping

the introduction of ingredients and intermediate products into the process flow

the introduction of products for reworking

Form 4: Plant schematic

Description of Form 4: Plant schematic

Form 4 can be used to illustrate the plant schematic. The name of the process or product is described on the first line. Your plan schematic should illustrate:

the flows of raw products, ingredients and finished products

the flows of packaging materials

the employee traffic pattern throughout the establishment including change rooms washrooms and lunchrooms

the flows of the waste, inedible products and other non-food products that could cause cross-contamination

the hand/boot washing and sanitizing installations

Form 5: Biological hazard Identification

Description of Form 5: Biological hazard Identification

Form 5 can be used to describe the biological hazards associated with the ingredients and incoming materials, processing steps or cross-contamination points. The name of the process or product is described on the first line.

Column 1
In column 1 you list and describe the biological hazards identified.

Column 2
In column 2 you identify the processing step at which each biological hazard (listed in column 1) is controlled.

Form 6: Chemical hazard identification

Description of Form 6: Chemical hazard identification

Form 6 can be used to describe the chemical hazards associated with the ingredients and incoming materials, processing steps or cross-contamination points you identify. The name of the process or product is described on the first line.

Column 1
In column 1 you list and describe the chemical hazards identified.

Column 2
In column 2 you identify the processing step at which each chemical hazard (listed in column 1) is controlled.

Form 7: Physical hazard identification

Description of Form 7: Physical hazard identification

Form 7 can be used to describe the chemical hazards associated with the ingredients and incoming materials, processing steps or cross-contamination points you identify. The name of the process or product is described on the first line.

Column 1
In column 1 you list and describe the physical hazards identified.

Column 2
In column 2 you indicate the processing step at which each physical hazard (listed in column 1) is controlled.

Form 8: CCP determination and other control measures

Description of Form 8: CCP determination and other control measures

Form 8 can be used to determine CCPs and other control measures. The name of the process or product is described on the first line.

Column 1
Under column 1 you list each ingredient and incoming material, process step and cross-contamination point for which a hazard or hazards were identified. Use one line per hazard.

Column 2
In column 2 you identify the category of each hazard identified (biological, chemical or physical) and fully describe each hazard. Where multiple hazards exist, each one is subject to the questions that follow.

You determine if each hazard is controlled by one or more prerequisite program. If the answer is "yes", for each hazard you identify the prerequisite program and the control measures applied in that program that controls the hazard.

If the HACCP team determines that the hazard is not fully controlled by a prerequisite program, proceed to Question 1.

Question 1
For each hazard you ask the questions:

Could you apply a control measure at a process step?

Could a control measure be applied at this step, or at any other process step, to control the hazard? Do you have or could you add a process step to control the hazard?

If the answer is "yes", describe the control measure and proceed to Question 2.

If the answer is "no" (a control measure cannot be implemented at a process step), identify how the hazard will be controlled before or after the manufacturing process (see form 9) and proceed to the next identified hazard.

Question 2
For each hazard you ask the questions:

Can the hazard increase to an unacceptable level and present a risk of contamination to the food?

If information gathered suggests that the hazard could increase to an unacceptable level and present a risk of contamination to the food, the answer is "yes". Proceed to Question 3.

If the hazard is not likely to increase to an unacceptable level, or does not pose a risk of contamination to the food, the answer is "no". Proceed to the next hazard.

Question 3
For each process step you ask the following question:

Is the process step specifically designed to prevent, eliminate or reduce to an acceptable level the hazard?

If yes then the answer is "yes" and you designate this process step as a critical control point and indicate this in the last column.